Regulatory Affairs

ACADIA Pharmaceuticals Inc.; South San Francisco (CA); Hybrid; USD 190,000 - 237,000; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation

Equity awards

Job summary

ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through commercialization. You will advance development, regulatory submissions, and lifecycle management across key regions including GCC, LATAM, and APAC.

You will serve as the CMC expert on cross-functional teams, guide interactions with authorities, and drive lifecycle activities while managing a team and ensuring timely submissions.

Qualifications

• Bachelor's degree in life science or related field.
• 10 years of progressive experience in CMC Regulatory Affairs for small molecules, with 5 years in management.
• Experience preparing CMC sections of INDs/CTAs/NDAs and ex-US MAA submissions.
• Ability to work in a cross-functional team environment and manage competing priorities.

Responsibilities

• Lead CMC regulatory affairs for marketed products and development programs.
• Coordinate with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues to shape CMC strategy.
• Prepare high-quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission.
• Serve as regulatory representative with external parties and act as contact with agencies for CMC development and lifecycle.
• Support regulatory function on development teams providing CMC guidance and strategy.
• Ensure compliance of CMC activities with applicable regulatory requirements.
• Evaluate manufacturing processes and changes and assess regulatory implications.

Skills

Regulatory CMC expertise

Leadership

Cross-functional collaboration

IND/CTA submissions

Global regulatory

Education

Bachelor's degree in life science

Job description

Please note that this position can be based in San Diego, CA, San Francisco, CAOR Princeton, NJ. Acadia'shybrid modelrequires this role to work in our office three days per week on average

Position Summary

Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization worldwide. In this leadership position, you will develop and execute global regulatory CMC strategies that support clinical development, marketing approvals, and lifecycle management across key regions including GCC, LATAM, and APAC. You will serve as the regulatory CMC expert on cross-functional teams, guide global regulatory interactions, and help shape successful development and commercialization strategies for our product portfolio. This is an opportunity to make a meaningful impact on programs that bring important therapies to patients around the world.

Primary Responsibilities

• Manages the CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements
• Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy
• Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities supporting the conduct of clinical trials and marketing applications worldwide
• Contributes as a key regulatory representative with external parties and acts as a point of contact with regulatory agencies for CMC development, product registration, and life-cycle activities
• Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks
• Participates in ensuring compliance of CMC activities with applicable regulatory requirements
• Evaluates Manufacturing processes and changes, assesses the regulatory implications and supports their implementation
• Maintains current knowledge of the relevant guidelines and regulations and determines applicability to company activities
• Other duties as assigned

Education/Experience/Skills

• Bachelor’s degree in life science or a related field. An equivalent combination of education and experience may be considered
• Targeting 10 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development, with 5 years in a management role
• Knowledge and understanding of global regulatory CMC requirements and guidelines
• Previous experience in the preparation and submission of the CMC components of IND/CTA filings as well as regulatory authority meeting Briefing Packages and NDA and ex-US MAA submissions
• Ability to work in a cross-functional team environment and manage competing priorities
• Strong interpersonal skills, attention to detail and excellent organizational skills
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting
• Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and ability to handle multiple project assignments
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization
• Self-directed and resourceful, with the ability to anticipate needs, identify opportunities, and drive work forward independently
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals
• Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$189,700—$237,100 USD

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [e-mail] or 858-261-2923.

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